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Instruction Manual
https://www.omron-healthcare.com/manuals/heartguide
HeartGuide (HEM-6411T-MAE)
x 2
Instruction Manual 1
Instruction Manual
2
< Front >
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Instruction Manual
3.
Full
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HeartAdvisor
HeartAdvisor
2893303-1 B
IM2-HEM-6411T-MAE-02-10/2019
Issue Date/Date de publication/Ausgabedatum/Data di pubblicazione/
Fecha de publicación/Uitgiftedatum: 2019-09-09
?
Wearable Blood Pressure Monitor
(HEM-6411T-MAE)
Read Instruction manual
and
before use.
Instruction Manual
EN
Instruction
Manual
1
< Back >
10217
5.1km 328kcal
ON / OFF
L / R
+3sec.
+3sec.
Clear All
Cancel
[ ON ]
OFF
[ L ]
R
Bluetooth OFF
Bluetooth OFF
+3sec.
+3sec.
Cleared
+7sec.
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Instruction Manual
3.
6h 24
80% /
17/5-18/5
8h00
SYS
mmHg
DIA
mmHg
PULSE
/
min
78
70
118
17/5 8
:
38
10217
5.1km 328kcal
6h 40
80% /
17/5-18/5
8h00
SYS
mmHg
DIA
mmHg
PULSE
/
min
78
70
118
17/5 8
:
38
SYS
mmHg
DIA
mmHg
PULSE
/
min
78
70
118
Canceled
HeartAdvisor
Error
xxx
≤1sec.
8
Wearable Blood Pressure Monitor
HeartGuide (HEM-6411T-MAE)
Read the instruction manuals before use.
Important safety information is in Instruction Manual
.
How to set up the wrist monitor is in Instruction Manual
.
IM1-HEM-6411T-MAE-01-06/2019
2893297-3A
Issue Date: 2019-08-08
1. Introduction
Thank you for purchasing the OMRON HEM-6411T-MAE Automatic Wrist Blood Pressure
Monitor. This blood pressure monitor is to be worn on your wrist. This blood pressure
monitor uses the oscillometric method of blood pressure measurement. When the band
in ates, the monitor senses the pressure pulsations of the artery underneath the band.
The pulses are called oscillometric pulses. The electronic pressure sensor displays a
digital reading of blood pressure.
This monitor can also track other measurements.
Activity measurement
This monitor tracks steps and calculates calories burned and distance.
Sleep measurement
This monitor measures hours slept and awake time.
1.1 Safety Instructions
This instruction manual provides you with important information about the OMRON
HEM-6411T-MAE Automatic Wrist Blood Pressure Monitor. To ensure the safe and
proper use of your monitor, READ and UNDERSTAND all of the safety and operating
instructions. If you do not understand these instructions or have any questions, contact
your OMRON retail outlet or distributor before attempting to use this monitor. For
speci c information about your own blood pressure, consult with your physician.
1.2 Intended Use
The device is a digital monitor intended for use in measuring blood pressure and pulse
rate in adult patient population with wrist circumference ranging from 16 to 19 cm. This
monitor detects the appearance of irregular heartbeats during measurement and gives a
warning signal with readings. It is mainly designed for general household use.
1.3 Receiving and Inspection
Remove this monitor from the packaging and inspect for damage. If this monitor is
damaged, DO NOT USE and consult with your OMRON retail outlet or distributor.
2. Know Your Monitor
a
b
c
d
g
f
e
a Display e Charging port
b [START/STOP] button f C u
c [FORWARD] button g Band
d
[HOME] button
Press this button from any screen to
go back to HOME screen.
h i j
h Charging clip
j
Cuff sleeve
To use your monitor comfortably, install the
cu sleeve to the cu of the monitor.
i AC adapter
2018 ESH/ESC
*
Guidelines for the management of arterial hypertension
De nitions of hypertension by o ce and home blood pressure levels
O ffi c e Home
Systolic Blood Pressure ≥ 140 mmHg ≥ 135 mmHg
Diastolic Blood Pressure ≥ 90 mmHg ≥ 85 mmHg
These ranges are from statistical values for blood pressure.
* European Society of Hypertension (ESH) and European Society of Cardiology (ESC).
Blood pressure level indicator (color)
When your systolic or diastolic blood pressure is above the ESC/ESH Guidelines, the
number will be shown in red. Refer to “2018 ESH/ESC Guidelines for the management
of arterial hypertension” for more information.
3. Important Safety Information
Read the Important Safety Information in this instruction manual before using this
monitor. Follow this instruction manual thoroughly for your safety. Keep for future
reference. For speci c information about your own blood pressure, CONSULT WITH
YOUR PHYSICIAN.
3.1 Warning
Indicates a potentially hazardous situation which, if not avoided,
could result in death or serious injury.
DO NOT use this monitor on infants, toddlers, children or persons who cannot express
themselves.
DO NOT adjust medication based on readings from this blood pressure monitor. Take
medication as prescribed by your physician. ONLY a physician is quali ed to diagnose
and treat high blood pressure.
DO NOT use this monitor on an injured arm or an arm under medical treatment.
DO NOT wear this monitor on your wrist while on an intravenous drip or blood
transfusion.
DO NOT use this monitor in areas containing high frequency (HF) surgical equipment,
magnetic resonance imaging (MRI) equipment, computerized tomography (CT)
scanners. This may result in incorrect operation of the monitor and/or cause an
inaccurate reading.
DO NOT use this monitor in oxygen rich environments or near  ammable gas.
Consult with your physician before using this monitor if you have common
arrhythmias such as atrial or ventricular premature beats or atrial  brillation; arterial
sclerosis; poor perfusion; diabetes; pregnancy; preeclampsia or renal disease. NOTE
that any of these conditions in addition to patient motion, trembling, or shivering may
a ect the blood pressure measurement reading.
NEVER diagnose or treat yourself based on your readings. ALWAYS consult with your
physician.
To help avoid strangulation, keep the AC adapter cable away from infants, toddlers or
children.
This product contains small parts that may cause a choking hazard if swallowed by
infants, toddlers or children.
Data Transmission
This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this
product in locations where RF is restricted, such as on an aircraft or in hospitals. Turn
o the Bluetooth® feature in this monitor, remove batteries and/or unplug the AC
adapter in those areas.
AC Adapter Handling and Usage
DO NOT use the AC adapter if the monitor or the AC adapter cable is damaged. If this
monitor or the AC adapter cable is damaged, turn o the power and unplug the AC
adapter immediately.
Plug the AC adapter into the appropriate voltage outlet. DO NOT use in a multi-outlet plug.
NEVER plug in or unplug the AC adapter from the electric outlet with wet hands.
DO NOT disassemble or attempt to repair the AC adapter.
Dry your hands before touching the AC Adapter, the charging clip and the the device
charging electrodes.
Keep the AC adapter, the charging clip and the device charging electrodes dry at all times.
Rechargeable Battery Handling and Usage
The rechargeable battery has been speci cally designed for this monitor. DO NOT use it in
any other devices.
DO NOT recharge the rechargeable battery once it has been removed from this monitor.
DO NOT dispose of the battery in a  re.
DO NOT crush or puncture the battery because it may cause spontaneous  ames.
DO NOT disassemble or modify the battery.
DO NOT connect the + and – poles using a piece of metal or other conductive objects.
< HOME screen >
DO NOT carry it or store it together with item such as necklaces and hair pins.
DO NOT recharge, use, or leave the battery in any high temperature environment such as
in a location near a  re or in direct sunlight. Doing so may cause the battery to overheat,
ignite or rupture.
DO NOT leave the battery that has been removed within the reach of infants, toddlers,
children or pets. Doing so may result in an injury or an accident. If liquid comes in contact
with the battery, a  re or an accident may occur.
This monitor has a built-in rechargeable battery. To prevent the risk of overheating,  re
or explosion, DO NOT throw into  re, apply heat, puncture or crush, use or leave in a high
temperature environment.
3.2 Caution
Indicates a potentially hazardous situation which, if not avoided, may
result in minor or moderate injury to the user or patient or damage to
the equipment or other property.
Stop using this monitor and consult with your physician if you experience skin irritation
or discomfort.
DO NOT use this device if you have a metal allergy.
Keep this monitor clean. If this monitor is causing skin irritation due to sweat or
contamination, stop using it and consult with your dermatologist.
Prolonged rubbing and pressure may irritate the skin. Give your wrist a break by
removing the monitor for a while after extended wear.
DO NOT let chemical products such as lotions, oils, skin creams or cosmetics collect on the
band. To avoid damage to the band material, make sure to wipe o any chemical products
that have collected on the band.
Consult with your physician before using this monitor on an arm where intravascular
access or therapy, or an arteriovenous (A-V) shunt, is present because of temporary
interference to blood  ow and could result in injury.
Consult with your physician before using this monitor if you have had a mastectomy.
Consult with your physician before using this monitor if you have severe blood  ow
problems or blood disorders as cu in ation can cause bruising.
DO NOT take measurements more often than necessary because bruising, due to
blood  ow interference, may occur.
ONLY in ate the cu when it is applied on your wrist.
Remove the band if it does not start de ating during a blood pressure measurement.
During measurement, make sure that no mobile device or any other electrical device
that emits electromagnetic  elds is within 30 cm of this monitor. This may result in
incorrect operation of the monitor and/or cause an inaccurate reading.
DO NOT disassemble or attempt to repair this monitor or other components. This may
cause an inaccurate reading.
DO NOT use in a location where there is moisture or a risk of water splashing this
monitor. This may damage this monitor.
The monitor and AC adapter are not designed for use in water or wet environments.
DO NOT use this monitor in a moving vehicle such as in a car or on an aircraft.
DO NOT drop or subject this monitor to strong shocks or vibrations.
DO NOT use this monitor in places with high or low humidity or high or low temperatures.
Refer to section 9.
Ensure this monitor is not impairing blood circulation by observing the arm while
measurement is occurring.
DO NOT use this monitor in high-use environments such as medical clinics or physician o ces.
DO NOT use this monitor with other medical electrical (ME) equipment simultaneously.
This may result in incorrect operation of the monitor and/or cause an inaccurate reading.
ONLY use this monitor on persons whose wrist circumference is within the speci ed
range of the cu .
Ensure that this monitor has acclimated to room temperature before taking a
measurement. Taking a measurement after an extreme temperature change could
lead to an inaccurate reading. OMRON recommends waiting for approximately 2 hours
for the monitor to warm up or cool down when the monitor is used in an environment
within the temperature speci ed as operating conditions after it is stored either at
the maximum or at the minimum storage temperature. For additional information of
operating and storage/transport temperature, refer to section 9.
DO NOT use this monitor after the durable period has ended. Refer to section 9.
DO NOT crease the band excessively.
DO NOT use the blood pressure measuring function for any other purpose.
DO NOT use this monitor to diagnose sleep disorders.
Consult with your physician or healthcare provider if you begin a weight reduction or
exercise program.
Keep the product out of the reach of infants, toddlers and children.
Avoid bathing, drinking alcohol or ca eine, smoking, exercising and eating for at least
30 minutes before taking a measurement.
Rest for at least 5 minutes before taking a measurement.
Remove tight- tting, thick clothing and any accessories from your arm while taking a
blood pressure measurement.
Remain still and DO NOT talk while taking a measurement.
AC Adapter Handling and Usage
DO NOT plug the AC adapter cable into any device other than this monitor.
Fully insert the AC adapter into the outlet.
When unplugging the AC adapter from the outlet, be sure to safely pull from the AC
adapter. DO NOT pull from the AC adapter cable.
When handling the AC adapter cable:
DO NOT damage it. / DO NOT break it. / DO NOT tamper with it. / DO NOT pinch it. /
DO NOT forcibly bend or pull it. / DO NOT twist it.
DO NOT use it if it is gathered in a bundle.
DO NOT place it under heavy objects.
Wipe any dust o of the AC adapter.
Unplug the AC adapter when not in use.
Unplug the AC adapter before cleaning this monitor.
ONLY use the AC adapter speci ed for this monitor. Use of unsupported AC adapters
may damage and/or may be hazardous to this monitor.
Rechargeable Battery Handling and Usage
DO NOT charge the battery when the AC adapter is wet.
4. Turn Your Monitor O
Press and hold the middle and lower button at the same time for more than 7 seconds
to turn o your monitor.
THU 17
8
:
38
Continue to the back side
5. Error Messages and Troubleshooting
If any of the below problems occur during measurement, check to make sure that no other
electrical device is within 30 cm. If the problem persists, please refer to the table below.
Display/
Problem
Cause Solution
Irregular heartbeat
detected.
Remove your monitor. Wait for 2 - 3 minutes
and then take another measurement. Repeat
the steps in Instruction Manual
. If this error
continues to appear, we recommend that you
consult with your physician.
Your body
moved during a
measurement.
Carefully read and repeat the steps in
Instruction Manual
.
Your monitor is
not at the correct
height.
Adjust the height of your wrist following the heart
zone indicator. Refer to step 8
of Instruction
Manual
.
Due to di erences in individual size and
physique, this feature may not be helpful in
all cases. If you feel the position of the wrist
does NOT match your heart level, turn o this
feature and follow your judgment. To disable
this feature, refer to back side of Instruction
Manual
.
The battery is
depleted.
Charge the battery. Refer to step 2 of
Instruction Manual
.
The monitor cannot
connect to a smart
device or transmit
data correctly.
Follow the instructions shown in the
“HeartAdvisor app. If it still appears after checking
the app, contact your OMRON retail outlet or
distributor. Refer to “www.omron-healthcare.com”
for contact information.
The band is not
applied correctly.
Apply the band correctly, then take another
measurement. Refer to step 7 of Instruction
Manual
.
Air is leaking from
the cu .
Contact your OMRON retail
outlet or distributor. Refer to
“www.omron-healthcare.com” for contact
information.
Clothing is
interfering with the
band.
Remove any clothing interfering with the
band.
The band may be
applied too loosely.
Apply the band correctly, then take another
measurement. Refer to step 7 of Instruction
Manual
.
The cu was in ated
exceeding the
maximum allowable
pressure.
Do not touch your monitor while taking a
measurement.
You move or
talk during a
measurement.
Vibrations disrupt a
measurement.
Remain still and do not talk during a
measurement.
The band was not
applied correctly or
was moved during a
measurement.
Apply the band correctly, then take another
measurement. Refer to step 7 of Instruction
Manual
.
Remain still and sit correctly during a
measurement.
12
:
35
Error
Error 1
Error 2
Error 3
Error 4
Error 5
The detailed user manual for the HeartGuide is now
available on the web. Scan the QR code below using
your smartphone or type the URL below to access our
web instruction manual.
https://www.omron-healthcare.com/manuals/heartguide
Instruction Manual
Manufacturer
OMRON HEALTHCARE Co., Ltd.
53, Kunotsubo, Terado-cho, Muko, KYOTO, 617-0002 JAPAN
EU-
representative
OMRON HEALTHCARE EUROPE B.V.
Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS
www.omron-healthcare.com
Importer in EU
Production facility OMRON HEALTHCARE Co., Ltd.
Matsusaka Factory
1855-370, Kubo-cho, Matsusaka-shi, Mie, 515-8503 Japan
Subsidiaries OMRON HEALTHCARE UK LTD.
Opal Drive, Fox Milne, Milton Keynes,
MK15 0DG, UK
www.omron-healthcare.com
OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH
Konrad-Zuse-Ring 28, 68163 Mannheim, GERMANY
www.omron-healthcare.com
OMRON SANTÉ FRANCE SAS
3, Parvis de la Gare, 94130 Nogent-sur-Marne, FRANCE
www.omron-healthcare.com
Made in Japan
①EN ②FR ③DE ④IT ⑤ES
⑥NL
19G1627
Display/
Problem
Cause Solution
Your wrist is moved
up and down during
a measurement.
Take another measurement making sure not to
move your wrist.
Temperature error is
detected.
Wait for few minutes, then take another
measurement in a place with moderate room
temperature. If the error appears again, contact
your OMRON retail outlet or distributor. Refer
to www.omron-healthcare.com” for contact
information.
The monitor has
malfunctioned.
The band may be
applied too tightly.
Apply the band correctly, then take another
measurement. Refer to step 7 of Instruction
Manual
.
Room temperature
is too high to charge
the battery.
Charge the battery at a moderate room
temperature.
The monitor has
malfunctioned.
If the error appears in moderate temperature,
contact your OMRON retail outlet or distributor.
Refer to “www.omron-healthcare.com” for
contact information.
Error
xxx
The monitor has
malfunctioned.
Turn o your monitor, then turn on your
monitor again. To turn o your monitor, refer
to section 4.
If the error still appears, contact your
OMRON retail outlet or distributor. Refer to
“www.omron-healthcare.com” for contact
information.
If 3 digit number
is displayed.
(“xxx” is 3 digit
number.)
The monitor
cannot be
operated.
Nothing appears on the display of
the monitor.
Charge the battery. Refer to step 2 of Instruction
Manual
.
Your monitor is turned o. Refer to step 3 of
Instruction Manual
to turn on your monitor.
Readings appear too high or too
low.
Blood pressure varies constantly. Many factors
including stress, time of day, and/or how
you apply the band, may aect your blood
pressure.
Any other communication issue
occurs.
Follow the instructions shown in the smart device,
or visit the “Help section in the “HeartAdvisor”
app for further help. If the problem still persists,
contact your OMRON retail outlet or distributor.
Refer to “www.omron-healthcare.com” for contact
information.
The monitor or the AC adapter is
abnormally hot when charging the
battery.
The monitor or the AC adapter may be damaged.
Unplug the AC adapter from the outlet immediately
and contact your OMRON retail outlet or
distributor. Refer to “www.omron-healthcare.com”
for contact information.
The operating time is short, or the
monitor does not operate, even
when the battery is fully charged.
This may be due to the life of the rechargeable
battery. The battery cannot be replaced. Contact
your OMRON retail outlet
or dispose of your
monitor.
Refer to “www.omron-healthcare.com”
for contact information.
6. Useful Functions
The HeartGuide has some useful functions other than taking blood pressure/activity/
sleep measurements. These functions can be set using “HeartAdvisor app. Refer to the
app for more detail about these functions.
6.1 Receiving Notication from Your Smart Device
Your monitor receives a notication (phone call, message and email) from your smart device.
When your monitor receives a notication, your monitor vibrates.
Press any button to close the notication.
6.2 Receiving a Reminder
The reminder function will alert you at a specic time of day with vibration and the
“Reminder” icon on the display.
6.3 Recording an Event
You can record the time of your action or activity as an “Event”, such as time you ate,
took a medicine, exercised or had another event.
Press and hold the button (
)
for more than 3 seconds, then check” mark appears.
7. Limited Warranty
Thank you for buying an OMRON product. This product is constructed of high quality
materials and great care has been taken in its manufacturing. It is designed to give you
every satisfaction, provided that it is properly operated and maintained as described in
the instruction manual.
This product is warranted by OMRON for a period of 2 years after the date of purchase.
The proper construction, workmanship and materials of this product is warranted by
OMRON. During this period of warranty OMRON will, without charge for labour or parts,
repair or replace the defect product or any defective parts. The warranty does not cover
any of the following:
A. Transport costs and risks of transport.
B. Costs for repairs and / or defects resulting from repairs done by unauthorised persons.
C. Periodic check-ups and maintenance.
D. Failure or wear of optional parts or other attachments other than the main device itself, unless
explicitly warranted above.
E. Costs arising due to non-acceptance of a claim (those will be charged for).
F. Damages of any kind including personal caused accidentally or from misuse.
G. Calibration service is not included within the warranty.
Should warranty service be required please apply to the dealer whom the product was
purchased from or an authorised OMRON distributor. For the address refer to the product
packaging / literature or to your specialised retailer. If you have diculties in nding
OMRON customer services, contact us for information: www.omron-healthcare.com
Error 7
Error 8
Error 9
Error
Repair or replacement under the warranty does not give rise to any extension or renewal
of the warranty period. The warranty will be granted only if the complete product is
returned together with the original invoice / cash ticket issued to the consumer by
the retailer.
8. Maintenance
8.1 Maintenance
Changes or modications not approved by the manufacturer will void the user warranty.
Caution
DO NOT disassemble or attempt to repair this monitor or other components.
8.2 How to Replace the Cu Sleeve
Replace the cu sleeve when it becomes dirty. It is recommended to replace the cu
sleeve after six months of use.
See illustration below to detach the cu sleeve and install another cu sleeve. Refer to
foreside of Instruction Manual
.
8.3 Storage
Store your monitor in a clean, safe location.
Do not store your monitor:
If your monitor is wet.
In locations exposed to extreme temperatures, humidity, direct sunlight, dust or
corrosive vapors such as bleach.
In locations exposed to vibrations or shocks.
8.4 Cleaning
Clean the cu sleeve when it becomes dirty (once-a-week cleaning is recommended).
Do not use any abrasive or volatile cleaners.
Use a soft dry cloth or a soft cloth moistened with neutral (mild) detergent to clean
your monitor and wrist cu, and then wipe them with a dry cloth.
Do not wash or immerse your monitor and wrist cu in water.
Do not use gasoline, thinners or similar solvents to clean your monitor and wrist cu.
Do not use a wet cloth on the plugs of the AC adapter, the AC adapter cable, or the
terminal of the charging clip.
Hand-wash with neutral (mild) detergent and air-dry the cu sleeve. Do not soak it in
water for long periods of time. Do not use any sterilization chemicals, disinfectants, or
softeners.
Caution
Stop using this monitor and consult with your physician if you experience skin
irritation or discomfort.
Prolonged rubbing and pressure may irritate the skin. Give your wrist a break by
removing your monitor for a while after extended wear.
Be careful not to let chemical products such as lotions, oils, skin creams or cosmetics
collect on the band. If this happens, wipe them immediately, otherwise it may impact
the material and lifetime of product.
8.5 Calibration and Service
The accuracy of this blood pressure monitor has been carefully tested and is designed
to last for the full service life.
The maintenance is limited to replacement of cu sleeve.
9. Specications
Product description Wearable Blood Pressure Monitor
Model (code) HeartGuide (HEM-6411T-MAE)
Product Category Electronic Sphygmomanometers
Display Transective memory-in-pixel LCD
Memory Blood pressure measurement: Up to 100 times
Activity measurement: Up to 7 days
Sleep measurement: Up to 7 times
Event: Up to 100 items
Transmission
method
Bluetooth® Low Energy
Wireless
communication
Frequency range: 2.4 GHz (2400 - 2483.5 MHz)
Modulation: GFSK
Eective radiated power: <20 dBm
Operation mode Continuous operation
IP classication Monitor: IP22 / AC adapter: IP22
Rating DC 3.8 V 3.0 W
Power source Built in Lithium ion polymer rechargeable battery (3.8V;
Approximately 164mAh)
AC adapter (INPUT AC100-240V, 50-60Hz 0.12-0.065A)
Battery lifespan Will last for approximately 500 cycles, 8 times/day
measurements in normal temperatures of 25 °C when new
battery fully charged.
Battery Life Up to 2 days (48 hours) battery life* per charge.
* Refer to “Battery Life Information” for the terms of the battery life.
Durable period
(Service life)
Monitor: 2 years / AC adapter: 2 years / Cu sleeve: 0.5 years
Operating
conditions
+5 to +40 °C / 15 to 90 % RH (non-condensing) /
800to1060hPa
Charging / data
transmission
conditions
+10 to +35 °C / 15 to 90 % RH (non-condensing) /
800to1060hPa
Storage conditions -20 to +40 °C / 10 to 90 % RH (non-condensing)
Transport
conditions
-20 to +60 °C / 10 to 90 % RH (non-condensing)
Weight Approximately 115 g
Dimensions Case diameter: Approximately 48 mm
Case thickness: Approximately 14 mm
Band width: Approximately 30 mm
Measurable wrist
circumference
160 to 190 mm
Contents Monitor, charging clip (HEM-CLIP-01), AC adapter (HHP-CH03),
2 replacement cu sleeves (HEM-CUCV-01), Instruction Manual
and
Applied part Type BF (cu )
Protection against
electric shock
Internally powered ME equipment
Maximum
temperature of the
applied part
Lower than +48 °C
Battery Life Information
The battery life is based on 2 days (48 hours) with the following use: in 23°C
environment, 170 mm wrist circumference, 8 times of blood pressure measurement
(inates to 150 mmHg) per day, 16-hour step counting per day, 8-hour sleep
measurement per day, 96 times of button pressing per day, 16 times of incoming call
per day, 1 time of ringing alarm per day, 16-hour Bluetooth communication per day.
The battery life depends on the terms of use and the environment of storage.
Blood pressure measurement
Cu pressure range 0 to 299 mmHg
Blood pressure
measurement range
SYS: 60 to 230 mmHg
DIA: 40 to 160 mmHg
Pulse measurement
range
40 to 180 beats / min.
Accuracy Pressure: ±3 mmHg / Pulse: ±5 % of display reading
Ination Automatic by electric pump
Deation Automatic rapid deation
Measurement
method
Oscillometric method
Activity / Sleep measurement
Measurement range Steps: 0 to 99,999 steps
Distance: 0.0 to 999.9 km / 0.0 to 621.3 mile
Time: 0:00 to 23:59
Calories burned: 0 to 59,999 kcal
Setting range Time: 0:00 to 23:59
Weight: 9.97 to 136.08kg (in increments of 0.01kg) /
22 to 300lb (in increments of 1lb)
Height: 100.00 to 199.00cm (in increments of 0.01cm) /
3'4
"
to 6'6
"
(in increments of 1inch)
Stride length: 30.00 to 121.92cm (in increments of 0.01cm) /
12
"
to 48
"
(in increments of 1inch)
Note
These specications are subject to change without notice.
This monitor is clinically investigated according to the requirements of
ISO81060-2:2013. In the clinical validation study, K5 was used on 85 subjects for
determination of diastolic blood pressure.
This monitor has not been validated for use on pregnant patients.
IP classication is degrees of protection provided by enclosures in accordance with
IEC 60529. This monitor and AC adapter protected against solid foreign objects of
12.5mm diameter and greater such as a nger, and against oblique falling water drops
which may cause issues during a normal operation.
Rating indication is printed on the cu.
Make sure not to place your monitor in a location where it is dicult to plug and
unplug the AC adapter.
About a wireless communication interference
This product operates in an unlicensed ISM band at 2.4GHz. In the event this Product
is used near other wireless devices such as microwave and wireless LAN, which operate
on the same frequency band as this Product, there is a possibility that interference may
occur. If interference occurs, stop the operation of the other devices or relocate this
Product away from other wireless devices before attempting to use it.
10. Correct Disposal of This Product (Waste Electrical &
Electronic Equipment)
This marking shown on the product or its literature, indicates that it should
not be disposed of, with other household wastes at the end of its working life.
To prevent possible harm to the environment or human health from uncontrolled
waste disposal, please separate this product from other types of wastes and
recycle it responsibly to promote the sustainable reuse of material resources.
Household users should contact either the retailer where they purchased this
product, or their local government oce, for details of where and how they
can return this item for environmentally safe recycling.
Business users should contact their supplier and check the terms and conditions of the pur-
chase contract. This product should not be mixed with other commercial waste for disposal.
To dispose this monitor, refer to www.omron-healthcare.com.
11. Important Information regarding Electromagnetic
Compatibility (EMC)
This device is manufactured by OMRON HEALTHCARE Co., Ltd. and conforms to the
EN60601-1-2:2015 Electromagnetic Compatibility (EMC) standard.
Further documentation in accordance with this EMC standard is available at
OMRON HEALTHCARE EUROPE at the address mentioned in this instruction manual
or at: www.omron-healthcare.com.
12. Guidance and Manufacturer’s Declaration
This blood pressure monitor is designed according to the European Standard
EN1060, Non-invasive sphygmomanometers Part 1: General Requirements and Part3:
Supplementary requirements for electromechanical blood pressure measuring systems.
Hereby, OMRON HEALTHCARE Co., Ltd., declares that the radio equipments type
HEM-6411T-MAE is in compliance with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet
address:
www.omron-healthcare.com
This OMRON product is produced under the strict quality system of
OMRONHEALTHCARECo., Ltd., Japan.
Please report to the manufacturer and the competent authority of the Member State
in which you are established about any serious incident that has occurred in relation
to this device.
13. Optional Accessories
Medical Accessory Other Accessories
Cu Sleeve
HEM-CUCV-01
AC Adapter
HHP-CH03 (for Europe)
Charging Clip
HEM-CLIP-01
HHP-BFH03 (for UK)
14. Symbols Description
Applied part - Type BF Degree
of protection against electric
shock (leakage current)
Class II equipment. Protection
against electric shock
Ingress protection degree
provided by IEC60529
CE marking
Serial number Medical device
Direct current Alternating current
Indication of connector
polarity
Temperature limitation
Humidity limitation Atmospheric pressure
limitation
The correct positioning for
the band on the wrist
Necessity for the user to
consult this instruction
manual
The correct positioning for
the monitor on the wrist
Date of manufacture
To indicate generally elevated,
potentially hazardous, levels
of non-ionizing radiation,
or to indicate equipment
or systems. e.g. in the
medical electrical area that
include RF transmitters or
that intentionally apply RF
electromagnetic energy for
diagnosis or treatment.
Eciency level of power
supply
Prohibited action
For indoor use only
The Bluetooth® word mark and logos are registered trademarks owned by the
Bluetooth SIG, Inc. and any use of such marks by OMRON HEALTHCARE Co., Ltd. is under
license. Other trademarks and trade names are those of their respective owners.
App Store and App Store logo are service marks of Apple Inc., registered in the U.S and
other countries.
Google Play and Google Play logo are trademarks of Google LLC.
https://www.omron-healthcare.com/
1

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